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Archive for the ‘Personalized and Precision Medicine & Genomic Research’ Category

3:15PM 11/12/2014 – Discussion Complex Disorders @10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Posted in Academic Publishing, Conference Coverage with Social Media, Personalized and Precision Medicine & Genomic Research, Scientific & Biotech Conferences: Press Coverage, tagged , , , , , , on November 12, 2014| Leave a Comment »

3:15PM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

 

3:15 p.m. Discussion Complex Disorders

Complex Disorders

During the past 30-40 years, it has become well established that most human disorders affecting large groups of individuals have a genetic basis. Based upon this information there are several efforts to conduct genetic analysis on very large populations of individuals to identify genetic factors that cause susceptibility to complex disorders. In this session, two examples where such studies are bearing fruit will be discussed.

Complex Disorders

Discussion Leader:

Anna Barker, Ph.D.
Director, Transformative Healthcare Knowledge Networks;
Co-Director, Complex Adaptive Systems Initiative:
Professor, School of Life Sciences, Arizona State University

World of Biomarkers following NIH Career – Molecular based Medicine

get all the facts right straight then distort them

Speakers:

Roy Perlis, MGH, Bipolar Specialty, Prof of Psychiatry

Specialist in Schizophrenia, Autism

  • Complexity – overlapping diseases, genomics discovery
  • Psychiatry Genomics – Susceptibility, variance explained by common variation, intervention studies for susceptibility
  • depression is hereditary
  • 2000 schizophrenics genome,
  • phenotype models is only partially indicative of help if you are on Klonopin, is this enough for the diagnosis
  • CRISPR — HOW to use it — not discovered yet for psychiatry disorder — it may be the solution, though

Joe Vockley

COO, Inova Health System

CSO, Inova Translational Medicine Institute

  • Preeclempsia – preterm Birth is a complex disease many factor can cause it, 12% of birth are Preterm birth
  • 10,000 genome vs full term birth, clinical phenotypes,
  • model 81% predictive — triage screening based on markers – genomics to follow phenotyping.
  • Genomics — indicative — not fully used from diagnostics to therapy
  • ancestor data (familial info) of the 10,000 in the cohort was done filter variant
  • whole genome sequencing, reimbursement does not support  to path to therapy based on genomics

Robert Plenge, M.D., Ph.D.   @rplenge
Vice President and Worldwide Head Genetics and Pharmacogenomics
Merck Research Laboratories – Specialist RA

ex- Pharmacogenetics at MGH

  • sample size 100,000 genomes completely sequenced  – PM is at present in Oncology – use Genetics to discover diagnostics markers, clinical diagnosis, protocols – worst in cancer
  • genetic effect are important component requires big cohort to identify large effect
  • dysfunctional variant
  • Proteomic predictors, in drug discovery not sufficient, marker of disease  it is helpful

 

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

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1:45PM 11/12/2014 – Panel Discussion – Oncology @10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Posted in Academic Publishing, Conference Coverage with Social Media, Personalized and Precision Medicine & Genomic Research, Scientific & Biotech Conferences: Press Coverage, tagged , , , , , , , , , , , , , , , , on November 12, 2014| Leave a Comment »

1:45PM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

 

1:45 p.m. Panel Discussion – Oncology

Oncology

There has been a remarkable transformation in our understanding of the molecular genetic basis of cancer and its treatment during the past decade or so. In depth genetic and genomic analysis of cancers has revealed that each cancer type can be sub-classified into many groups based on the genetic profiles and this information can be used to develop new targeted therapies and treatment options for cancer patients. This panel will explore the technologies that are facilitating our understanding of cancer, and how this information is being used in novel approaches for clinical development and treatment.

Oncology

Opening Speaker & Moderator:

Lynda Chin, M.D.
Department Chair, Department of Genomic Medicine
MD Anderson Cancer Center     @MDAnderson   #endcancer

  • Who pays for personalized medicine?
  • potential of Big data, analytics, Expert systems, so not each MD needs to see all cases, Profile disease to get same treatment
  • business model: IP, Discovery, sharing, ownership — yet accelerate therapy
  • security of healthcare data
  • segmentation of patient population
  • management of data and tracking innovations
  • platforms to be shared for innovations
  • study to be longitudinal,
  • How do we reconcile course of disease with personalized therapy
  • phenotyping the disease vs a Patient in wait for cure/treatment

Panelists:

Roy Herbst, M.D., Ph.D.    @DrRoyHerbstYale

Ensign Professor of Medicine and Professor of Pharmacology;
Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital     @YaleCancer

Development new drugs to match patient, disease and drug – finding the right patient for the right Clinical Trial

  • match patient to drugs
  • partnerships: out of 100 screened patients, 10 had the gene, 5 were able to attend the trial — without the biomarker — all 100 patients would participate for the WRONG drug for them (except the 5)
  • patients wants to participate in trials next to home NOT to have to travel — now it is in the protocol
  • Annotated Databases – clinical Trial informed consent – adaptive design of Clinical Trial vs protocol
  • even Academic MD can’t read the reports on Genomics
  • patients are treated in the community — more training to MDs
  • Five companies collaborating – comparison of 6 drugs in the same class
  • if drug exist and you have the patient — you must apply personalized therapy

 

Lincoln Nadauld, M.D., Ph.D.
Director, Cancer Genomics, Huntsman Intermountain Cancer Clinic @lnadauld @intermountain

  • @Stanford, all patients get Tumor profiles Genomic results, interpretation – deliver personalized therapy
  • Outcomes from Genomics based therapies
  • Is survival superior
  • Targeted treatment – Health economic impact is cost lower or not for same outcome???
  • genomic profiling of tumors: Genomic information changes outcome – adverse events lower
  • Path ways and personalized medicine based on Genomics — integration not yet been worked out

Question by Moderator: Data Management

  • Platform development, clinical knowledge system,
  • build consortium of institutions to share big data – identify all patients with same profile

 

 

 

 

See more at  http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

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1:15PM 11/12/2014 – Keynote Speaker – International Genetics Health and Disease @10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Posted in Academic Publishing, Conference Coverage with Social Media, Personalized and Precision Medicine & Genomic Research, Scientific & Biotech Conferences: Press Coverage, tagged , , , , , , , , on November 12, 2014| Leave a Comment »

1:15PM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

1:15 p.m. – Keynote Speaker – International Genetics Health and Disease

International Genetics Health and Disease

The principles of personalized medicine and how they affect the lives of people acknowledge no national boundaries. Although there are some differences among the diverse populations around the world in terms of their genetic variation, the general principles of personalized medicine apply uniformly across many populations. Dr. Periz will discuss how personalized medicine is viewed across the many European countries with particular emphasis on how Spain is implementing it into its medical care.

Keynote Speaker

Antonio L. Andreu Periz, M.D.
Director, Instituto de Salud Carlos III, Madrid

@insalud_es  @CIBER-BBN

Governmental & Public Health National Organization like a combination of CDC and “Hybrid NIH in the US”

Personalized Medicine (PM) in Europe

Europe and Spain — PM is changing Medical Practice, regulations standard of care.

 

In Europe 28 National systems in Spain alone 17 systems

Implementation of PM in Europe: Hospitals, Regulation,

  • develop proof of concept
  • identify mechanisms
  • bring basic research to clinical
  • incorporation into a Portfolio of policies on PM

Horizon 2020 in EU – 2016 launch action on PM in various countries in EU

  • Translational level for all EC members
  • Coalition of 28 Research Centers in Europe to promote PM
  • Sharing Databases, Data on HC, infrastructure for Translational research
  • OMICS
  • Biomarkers
  • clinical trials

CSA – Coordination Support Action

  • PerMed 500,000 Euro for 5 years, 9 operating partners, representatives of Ministry of Health, Israel and Canada Ministry of Health are included
  • Research Agenda for PM in Europe – SWOT Analysis
  • Recommendations for UC to start PM in 2016
  • – basic research
  • – translation
  • – ICTs
  • – Regulatory

SPAIN – Initiatives on PM: Aggregation of Knowledge

  • One single organization collaborates with 22 Institutions on Biomedical research – Concentration in Barcelona and in Madrid
  • Projects of Excellence: PhD level Projects – Clinical Practice: Imaging, Endocrinology, genomics, cardiology
  • 2014 — 35 Applicants – not all are on Cancer 25% are in Cancer 75% are in other clinical Fields
  • 12Million Euros will fund 1/4 of the applicants
  • PhD Thesis on PM – common project 2 yr governmental institute and 2 years in biotech industry

EAPM – Europe Alliance for PM

  • raise awareness on HOW PM CAN SHAPE Healthcare in Europe: Diagnosis, Treatment,
  • Specialized Treatment for Europe’s Patient (STEPs) – Five Steps

Global alliances to shape Medical Practice based on PM – Collaboration Industry and Academia

  • PMC in the US (Personalized Medical Coalition)
  • PerMEd in Europe (coalition  in Europe  supporting innovation in personalized medicine)
  • EAPM (European Alliance for Personalized Medicine)

 

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

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11:30AM 11/12/2014 – Personalized Medicine Coalition Award & Award Recipient Speech @10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

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11:30AM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

11:30 Personalized Medicine Coalition Award &  Award Recipient Speech

Presentation of Personalized Medicine Coalition’s 10th Annual Award for Leadership in Personalized Medicine.

Personalized Medicine Coalition Award Recipient

Mark J. Levin
Co-Founder and Partner
Third Rock Ventures, LLC

Presenter:

Brian Munroe
PMC Founder and Senior Vice President, Government Affairs
Endo

 Award in Science, Business Policy to individual to lead PM – Mark Levin

 

 

  • was at Ely Lilly in the 70s leading supplier of Insulin in the 20s and antibiotics in the 30s,Factor 8, pain drugs, chemotherapy
  • was at Genentech – Human growth Hormone and Human Insulin — both are PM, Interferon,
  • was at Mayfield Ventures
  • was at Millenium, CEO, early 90s, monoclonal antibodies
  • 2000 discussion on the need for PMC
  • Founder of Foundation Medicine – molecular informatics – expands therapeutics and PM
  • NOW — with Third Rock Ventures, LLC

 

Mark Levin – award acceptance speech – Team accomplishments most important

We need to thank the patients participating in Clinical Trials

  1. How I got involved in personalized medicine (PM): High School – Human Biology
  2. Genetics – drive
  3. PM – All diseases – genetic disorders — combination with extreme phenotyping, Muscular Dystrophy – splicing a gene for treatment
  4. Drugability and PM – gene therapy, replace factor, deliver a gene to the brain and the drug. inside CSF
  5. Gene editing – deliver to the Brain correct the gene in the Brain – therapy for ALS, Schizophrenia – understanding the genes involved in this disease, same
  6. Cancer cure – treatment of combination therapies several at the same time vs present time treat one other emerges
  7. cancer vaccine
  8. Sample of blood – proteomics — in Annual Exams at MDs Annual physical
  9. Convergent — comparison of Mutation across to 1000 patient’s mutations
  10. Future is MOST exciting
  11. Challenges of the Future: Biology and Technology, cells in microbiome, 10 million genes, SYSTEM BIOLOGY — will lead the way,
  12. FUNDING SCIENCE via NIH Scientist is the most important National task
  13. Preventative and Prognostics Medicine -need be part of DRUG development
  14. Justification – maximize value for patient vs $$ spent – maximum value – waste and no leadership
  15. Concern — Affordability of Healthcare to All, access to care vs economic Inequality
  16. Leadership and Management: We truly need NATIONAL CONVERSATION — with a Leader with set of goals to solve a problem in certain time
  17. Insurance, Pharma, HMO — budget challenge — attendees inn the room, need to provide leadership at the National Level

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

 

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11:00AM 11/12/2014 – Keynote Speaker – Past, Present and Future of Personalized Medicine @10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Posted in Academic Publishing, Conference Coverage with Social Media, Personalized and Precision Medicine & Genomic Research, Scientific & Biotech Conferences: Press Coverage, tagged , , , , , , on November 12, 2014| Leave a Comment »

11:00AM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

11:00 Keynote Speaker – Past, Present and Future of Personalized Medicine

Past, Present and Future of Personalized Medicine

Keynote Speaker

Mirella Marlow, M.A., M.B.A.
Programme Director, Centre for Health Technology Evaluation,
National Institute for Health and Clinical Excellence (NICE) @NICEcomms

PM in the UK

Clinical evidence and cost effectiveness needed for PM

UK Government life sciences policy

Scale of PM:

2013 – 10 million pound

2020 – 60 million pound

Innovative healthcare to promote economic growth

  • Genomics England 100,000  – new scientific discovery and kick start the UK genomics industry
  • BIS – accelerate Skills & Training for the Genomics Industries
  • UK Precision Medicine Catapult development of tests and commercialization of innovation in diagnostics

1 Billion Pound NIHR in UK

  • tissue banks – Biobank
  • Farr Institute – “big data”
  • develop methodologies for starter research

National Institute Care Excellence

– standards for NP

Benefits of PM

  • right treatment
  • responding subgroups
  • earlier treatments
  • dosing
  • reduce side effects

Companion Diagnostics in NICE – Technology Appraisals

  • elevate a test like evaluate a drug ad part of Diagnostics
  • Treatment: GIST — >>Biomarker: KitCD117

Diagnostics assessment Program

  • 9 EGFR-TK – mutation testing –
  • Mutation Analysis Services

NICE support to Companies – Company engagement

  • discuss product pipeline and value proposition
  • orientation to the process
  • Scientific Advice on Clinical Trial Design
  • workshops for Pharma and for Diagnostics — are different
  • online tool being developed – standardize the Advise for Fee — get Accredited Advisors in the Fields of Genomics, Diagnostics
  • Post guidance – evidence gaps, clinical utility and economic evidence
  • Update guidance – research questions guiding Guidance for the industry
  • Indirect Research facilitation: protocol external funding identify clinical context ethics +GCP leading to Publication within 2 years

UK and Genetics: Kirk and Watson on DNA

UK – 60 million patients under one National Universal Health Care System

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

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9:20AM 11/12/2014 – Panel Discussion – Genomic Technologies @10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Posted in Academic Publishing, Conference Coverage with Social Media, Personalized and Precision Medicine & Genomic Research, Scientific & Biotech Conferences: Press Coverage, tagged , , , , , , , , , , , , , , , , , , , , on November 12, 2014| Leave a Comment »

9:20AM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

9:20 a.m. Panel Discussion – Genomic Technologies

Genomic Technologies

The greatest impetus for personalized medicine is the initial sequencing of the human genome at the beginning of this Century. As we began to recognize the importance of genetic factors in human health and disease, efforts to understand genetic variation and its impact on health have accelerated. It was estimated that it cost more than two billion dollars to sequence the first human genome and reduction in the cost of sequence became an imperative to apply this technology to many facets of risk assessment, diagnosis, prognosis and therapeutic intervention. This panel will take a brief historical look back at how the technologies have evolved over the last 15 years and what the future holds and how these technologies are being applied to patient care.

Genomic Technologies

Opening Speaker and Moderator:

George Church, Ph.D.
Professor of Genetics, Harvard Medical School; Director, Personal Genomics

Genomic Technologies and Sequencing

  • highly predictive, preventative
  • non predictive

Shareable Human Genomes Omics Standards

$800 Human Genome Sequence – Moore’s Law does not account for the rapid decrease in cost of Genome Sequencing

Genome Technologies and Applications

  • Genia nanopore – battery operated device
  • RNA & protein traffic
  • Molecular Stratification Methods – more than one read, sequence ties
  • Brain Atlas  – transcriptome of mouse brains
  • Multigenics – 700 genes: hGH therapies

Therapies

  • vaccine
  • hygiene
  • age

~1970 Gene Therapy in Clinical Trials

Is Omic technologies — a Commodity?

  • Some practices will have protocols
  • other will never become a commodity

 

Panelists:

Sam Hanash, M.D., Ph.D. @MDAndersonNews

Director, Red & Charline McCombs Institute for Early Detection & Treatment of Cancer MD Anderson Cancer Center

Heterogeneity among Cancer cells. Data analysis and interpretation is very difficult, back up technology

Proteins and Peptides before analysis with spectrometry:

  • PM  – Immunotherapy approaches need be combined with other techniques
  • How modification in protein type affects disease
  • amplification of an aberrant protein – when that happens cancer developed. Modeling on a CHip of peptide synthesizer

Mark Stevenson @servingscience

Executive Vice President and President, Life Sciences Solutions
Thermo Fisher Scientific

Issues of a Diagnostics Developer:

  • FDA regulation, need to test on several tissues
  • computational environment
  • PCR, qPCR – cost effective
  • BGI – competitiveness

Robert Green, MD @BrighamWomens

Partners, Health Care Personalized Medicine — >>Disclosure: Illumina and three Pharmas

Innovative Clinical Trial: Alzheimer’s Disease, integration of sequencing with drug development

  • Population based screening with diagnosis
  • Cancer predisposition: Cost, Value, BRCA
  • epigenomics technologies to be integrated
  • Real-time diagnostics
  • Screening makes assumption on Predisposition
  • Public Health view: Phenotypes in the Framingham Studies: 64% pathogenic genes were prevalent – complication based in sequencing.

Questions from the Podium:

  • Variants analysis
  • Metastasis different than solid tumor itself – Genomics will not answer issues related to tumor in special tissues variability

 

 

 

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

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8:50AM 11/12/2014 – Keynote Speaker – CEO, American Medical Association @10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

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8:50AM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

8:50 a.m. – Keynote Speaker – CEO, American Medical Association

The American Medical Association (AMA) has the largest number of practicing physicians of all specialties as its members and the organization plays a very important role in health care policy and education of medical professionals.  AMA has been quite active in assessing the role of personalized medicine in the future of healthcare in all of its facets.  Dr. Madara will talk about the status of AMA’s thinking about personalized medicine and his vision of how it might be able to transform medical care.

Keynote Speaker

James Madara, M.D. @AmerMedicalAssn


Executive Vice President and CEO, American Medical Association

AMA Strategy the context for PM  – Outside looking in View applied

Mission statement: Promote Medicine 167 years since it was established. Societies of MDs – all population of American MDs, are members.

AMA developed:

  • CPT Curation – Billing of Procedures
  • Standard Procedure for Katrina and Emergency Medicine
  • Strategic Plan 110 active Projects to be compressed into three big ideas
  1. Connect clinics with community – OUTCOMES, cooperation with CDC i.e., Diabetes, HTN (KaiserPermanente)
  2. Medical education bring t to 21th century: Competence vs Time-in-Chair, 141 Medical Schools, teaching methods: Gaming/mobile, the lecture Hall in Medicine is poor form for education, Simulation methods, Clinical Research and Basic Research – blend across disciplines, platforms in Silicon Valley to create new TEACHING of MDs, Genomics must be incorporated, shifting from Inpatient to Outpatient to HOME, all training is for Inpatient – Nothing for HOME delivery of Care. 85% of all Medical School responded they need change in Teaching — 11 Excellence Medical Schools selected: Vanderbilt, MI, UCSF, UC Davis…
  3. Make practice of medicine joyous again – installation in MDs Offices, optimize the efficiency of MDs reporting now emphasis on USABILITY

Doing through Partnership: PM in Nutrition is everywhere — it is a HYPE, Gartner Group Hype Cycle was used by the Speaker for an analogy with Personalized Medicine (PM)

SHAKE out for a steady state in PM mitigation the hype

  • Mixed perceptions of Cost effectiveness of Healthcare delivery – Growth of Health Spending by Component:
  • Center on Outcomes and Values: PM redefined: away from behavioral toward procedural (actions): i.e, CV death risk predicted by waist size –

Cost/Behavior: sweet-spots are the following

  • Pharmaconeconomics: Is cost effective and it does not involve behavior
  • Cancer
  • Laboratory Developed Tests (LDTs)

– need be approved by FDA – New challenge in PM

– AMA View: Medical services not Medical Devices, CLIA ensure the quality and Standards, it requires more than guidance, currently FDA has ONLY guidance

 

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

 

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8:20AM 11/12/2014 – Special Guest Keynote Speaker – The Future of Personalized Medicine @10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

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8:20AM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of the Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

 

8:20 a.m. Special Guest Keynote Speaker – The Future of Personalized Medicine

The Future of Personalized Medicine

Special Guest Speaker

Margaret Hamburg, M.D.
Commissioner of Food and Drugs Administration

[Her Father was President of IOM said at the introduction to the Keynote]

How to ask the right question is what HMS taught me best 

Increasing the knowledge of Biology, response to disease, preventive strategies.

2004 — Monumental year — One year after completion of sequencing the Genome

2008/9 – Breast Cancer – pharmacotherapy approved, a protein involved in triggering the disease.Target therapy – risk of disease identified

WHAT FDA is doing on Genetics Information as PARTNERS in Medicine

25% of drugs approved are Targeted therapies

LABELING drugs on genetic information

diagnostics test — identify good respondents

Companion Diagnostics – should be used in Targeted therapies. IGF1, HER2 expression and amplification

PM more important in ONCOLOGY , HepB, Cystic Fibrosis, differential response, CVD – expansion, more to be done

In 2002 — a Program to discuss Genetic information VSDS – New Genomics Program, National Center for Toxicology Research a participants

Translational Scientist are added.

Completion Genome sequencing — push to PM 2011 – Genomics evaluation Team for Safety.

Challenge – Drug, Biologics – interaction need coordination by Agency to discuss challenges and collaboration with out side Group.

Developers of Targeted therapies: Orphan Drugs, Biomarkers – expedited review to promote innovations, fast track breakthrough therapies. Opportunities of Scientist to engage discussion with FDA

 – ALL hands on Deck Approach at FDA – making products available, i.e. SCLC (small cell lung cancer)

Since 2005 – 25 Guidance Reports, i.e., Orphan Drugs and on Companion Diagnostics to be developed in tandem with drug development.

Companion Diagnostics – 3 month review, enforcement and direction – in the framework

FDA — needs to keep up with development in the Diagnostics and in the disease ares.

Illumina – Assays using SNIPS – FDA assesses a shared curated DB on mutation, reduce the review time significantly

FDA – NGS – reference libraries, Genomics Reference and Storage of genomics data

Tools and Capabilities  – support regulatory and science, statistical methods of analysis — implemented for Breast Cancer — signaled the way of new Partnerships and New Clinical Trials formats and methods in its development.

New diagnostics – AMP Program Alzheimer’s Disease, rheumatoid arthritis (RA), inflammatory bowel syndrome (IBS)

What Science is needed for the Regulators to effectively HELP spar innovation.

Pharmacogenomics, Pharmacogenetics — MAPPING the Human Genome and all other areas of “OMICS” – moving from Lab to bedside — requires expertise in Disease prevention, Difference in patients life, Standard medical practice

  • Biology and Pathways
  • Biomarkers
  • New diagnostics
  • Increased communication Universities, new paradigms models and continual effort of SHARING and coordination of shared resources

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

 

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8:00AM 11/12/2014 – Welcome & Opening Remarks @10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Posted in Academic Publishing, Conference Coverage with Social Media, Personalized and Precision Medicine & Genomic Research, Scientific & Biotech Conferences: Press Coverage, tagged , , , , , on November 12, 2014| Leave a Comment »

8:00 AM – Welcome & Opening Remarks

Reporter: Aviva Lev-Ari, PhD, RN

REAL TIME Coverage of the Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

Speakers

Raju Kucherlapati, Ph.D.
Paul C. Cabot Professor of Genetics, Professor of Medicine, Harvard Medical School

Welcome all attendees, discussing Personalized Medicine, what happened and looking forward — the potential of this approach to Medicine. Event organized with Partner, National Council Cancer Research. Organizing committee and Sponsors made the event possible.

AND

Scott Weiss, M.D., M.S.
Scientific Director, Partners Personalized Medicine;
Associate Director, Channing Laboratory, Professor of Medicine.

Greetings

Greetings from the Institute of Medicine

Victor Dzau, M.D. — ABSENT — By Voice addressing the Audience
President, Institute of Medicine

Advisor on Genomics – In 1996 returned from Stanford to Harvard. What role Genetics and Genomics will play in Medicine.

Boston is a very special place for that endeavor. Harvard allocated $100 Million to study this topic. 10th year of the Conference. I am 100 days at IOM, Genomics and personalized medicine (PM) and Translation Medicine are the center. Spin off in Software development to solicit application in PM. Scientists, payers, technologists — the economics of PM navigate the regulatory. Looking forward for the next 10 years in PM

“10 Years in 10 Minutes: 10 Facts”

Edward Abrahams, Ph.D. (@newsfrompmc)
President, Personalized Medicine Coalition

Review the Progress made in PM – it has change, treating the patient not changing the disease. Friendlier  between Science and the Medicine.

  • 2004 Harvard graduate started Facebook, Viox was recalled,
  • Personalized Medicine – drugs increase form 13 in 2003 to 113 in 2013.
  • Diagnostics evolution by revolution
  • It took 4 years to develop new drug in 2013
  • In 20 years 45% of drug approvals – revolution in 155 Pharmacogenomics drugs approved at $12 Billion sales
  • FDA encouraged PM – 2017 Diagnostics
  • FDA molecular diagnostics test
  1. Regulatory of tests
  2. Payers and Manufacturer do not agree on practices
  3. Education of MDs in PM, 10% had sufficient knowledge in Genomics to incorporate it in Delivery of Care
Margaret Hamburg, MD
Commissioner of FDA

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

@HarvardPMConf

#PMConf

@SachsAssociates

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Hashtags and Twitter Handles for 10th Annual Personalized Medicine at Harvard Medical School, 11/12 – 11/13/2014

Posted in Conference Coverage with Social Media, Personalized and Precision Medicine & Genomic Research, Scientific & Biotech Conferences: Press Coverage on November 11, 2014| Leave a Comment »

Hashtags and Twitter Handles for 10th Annual Personalized Medicine at Harvard Medical School, 11/12 – 11/13/2014

Reporter: Stephen J Williams, PhD

10th Annual Personalized Medicine at Harvard (Partners Healthcare)

Meeting #: #PMConf

Meeting @: @HarvardPMConf

 PLEASE ALSO FOLLOW LIVE MEETING NOTES AT @pharma_BI OR AT http://pharmaceuticalintelligence.com/

Overall good meeting #s:

#personalizedmedicine

#powerofgenomics

#genomics

#pharmanews

@BiotechNews

Day Time Talk Title # @
Wed. Nov 12, 2014 8:00 AM Welcome & Opening Remarks #personalizedmedicine

#genomics

#Boston

#Harvard

#MGH

#biotech

#harvardhealth

 @PartnersNews

@MassGeneral

@AstellasUS (Stephen Eck)

@HarvardHealth

@harvardmed
Greetings #personalizedmedicine @theIOM (Dzau Institute of Medicine)

@newsfrompmc

(Personalized Medicine Coalition)
8:20 AM Special Guest Keynote Speaker Margaret Hamburg, M.D. #FDA

#personalizedmedicine

#FDACommissioner

#pharma

#healthcare

#PublicHealth

#HealthPolicy

 @US_FDA

@HIVForum

@AIDSAlliance_DC

@HHSGov
8:50 Keynote Speaker

James Madera, M.D.

 #AMA

#meded

#HealthPolicy

#personalizedmedicine

#healthcare

#physician

#PublicHealth

 @AmerMedicalAssn
9:20 Panel Discussion

Genomic Technologies

 #genomics

#genome

#personalizedmedicine

#health

#biotech

#lifesciences

#syntheticbiology

#startups

#startup

#disease

#endcancer

#MDAnderson

 @harvardmed

@PartnersNews

@Harvard

@geochurch

@BrighamWomens

@MDAndersonNews

@servingscience (Thermo Fisher)
11:00 Keynote Mirella Marlow #personalizedmedicine

#UK

#health

#healthcare

#NIH

 @NIH

@NICEcomms

@MirellaMarlow
11:30 10th Annual Award for Personalized Medicine #personalizedmedicine

#VC

#venturecapital

#startups

#startup

#VoyagerTherapeutics

#biotech

#biopharma

#partnership

#investing

 @VCapitalGuide

@hgbc_harvard

@MassBio

@MALifeSciences

@FierceBiotech
1:15 Keynote Speaker International Genetics Health and Disease #personalizedmedicine

#health

#disease

#populationgenetics

#spain

#medicine

#EU

#salud

 @insalud_es

@CIBER-BBN

@EIGlobalNet
1:45 Panel Discussion Oncology #oncology

#cancer

#bioinformatics

#genetics

#technologies

#endcancer

#personalmed

MAKE LINK TO VIDEO

 @MDAndersonNews

@MDAnderson

@DrRoyHerbstYale

@YaleCancer

@lnadauld

@intermountain
3:20 Discussion #disease

#populationgenetics

#health

#geneticfactors

#PopulationHealth

#epidemiology

#genome

#merck

#risk

 @WeillCornell

@ASU (for Anna Barker)

@rplenge

@Merck
4 pm Panel Discussion Novel Approaches to Personalized Medicine #personalizedmedicine

#personalmed

#genetictesting

#biomarker

#oncology

#diseasedetection

#geneticcounseling

#partnership

#startup

#biotech

#executiveMBA

 @cardinalhealth

@Sarepta

@KEWGroup

@MolecularHealth

10th Annual Personalized Medicine at Harvard (Partners Healthcare)

DAY TWO (Thursday 11/13, 2014)

Meeting #: #PMConf

Meeting @: @HarvardPMConf

Day Time Talk Title # @
Thurs. Nov 13, 2014 8:00 AM Welcome from Gary Gottlieb, M.D. #personalizedmedicine

#genomics

#Boston

#Harvard

#harvardmed

#biotech

#harvardhealth

 @PartnersNews

@MassGeneral

@HarvardHealth

@harvardmed

@BrighamWomens
8:30 AM Harvard Business School Case Study: 23andMe #genetictesting

#personalizedmedicine

#management

#diagnostic

#clinical

#HealthPolicy

#DigitalHealth

#innovation

#geneticcounseling

 @HarvardHBS

@harvardmed

@23andMe
10:15 AM Panel Discussion: IT/Big Data #BigData

#sequencing

#NGS

#clinicalresearch

#genetictesting

#bioinformatics

#oncology

#cancer

#health

#diagnostic

#genome

#epidemiology

 @Duke_Medicine

@AstellasUS

@GoogleVentures

@harvardmed

@BrighamWomens

@kyeshwant
11:30 AM Keynote Speaker: Role of Genetics and Genomics in Pharmaceutical Develpment #genetics

#genomics

#pharma

#pharmanews

#neurodegenerative

#brain

#Alzheimers

#HuntingtonsDisease

#cancer

#oncology

 @EliLillyCo

@LillyHealth

@FiercePharma

@PharmaNews

@medicalnews
1:00 PM Genomics in Prenatal and Childhood Disorders #genomics

#pediatriccancer

#ChildhoodCancer

#research

#childhood#disease

#diagnosis

#Healthcare

 @MGH

@MassGeneral

@Tufts

@MedscapePeds

@ClinicSpecChild

@InovaHealth
2:15 PM Panel Discussion: Reimbursement and Regulation #personalizedmedicine

#powerofgenomics

#HealthCare

#healthpolicy

#healthinsurance

#ACA

#patientchat

 @GenomeQuebec

@clopezcorrea

@Aetna (for Dr. Kolodziej)

@FoleyHoag (for Bruce Quinn)
3:30 PM Closing Remarks

Raju Kucherlapati, Ph.D.

 #personalizedmedicine

#pharmanews

 @harvardmed

@BiotechNews
4 pm

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